Clinical trial: Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

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Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: alosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Clinical Details

Official title: A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Secondary outcome: Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:
- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

- Failed conventional therapy.

- Willing to make daily calls on a touch-tone telephone.
Exclusion criteria:
- History of or current chronic or severe constipation.

- Bloody diarrhea, abdominal pain with rectal bleeding.

- Thrombophlebitis.

- Abnormal thyroid stimulating hormone (TSH) value.

- Alcohol and/or substance abuse within past two years.

- Pregnant or lactating.

- History/treatment of malignancy within past five years.

Locations and Contacts

GSK Clinical Trials Call Center, Tallassee, Alabama 36078, United States
GSK Clinical Trials Call Center, Pell City, Alabama 35128, United States
GSK Clinical Trials Call Center, Huntsville, Alabama 35801, United States
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Additional Information

Starting date: June 2003
Last updated: September 24, 2007

Page last updated: June 20, 2008

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